Harbir S Makin Md

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the Quality Control Policy, Quality Control records, and an interview with the Testing Person, the laboratory failed to follow its policy for ensuring Quality Control result acceptability prior to reporting patient test results for Chloride on the Alfa Wasserman Ace Axcel analyzer 62 out of 143 testing days from 5 /4/2023 to 10/23/2024. Findings include: 1. The laboratory's Quality Control Policy states that patient results may not be reported unless control results meet quality control acceptability criteria. 2. A review of Quality Control results for Chloride on the Alfa Wasserman Ace Axcel revealed the Level 2 Chemistry Control for Chloride was not within the manufacturer's acceptable range 62 of 143 days patients were tested from 5/4/2023 to 10/23/2024. 3. An interview conducted on 10/25/2024 at 11: 30 AM with the testing person confirmed these findings. 4. The laboratory reports running approximately 690 Chloride tests annually. D5781

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the laboratory's 2023 American Proficiency Institute (API) proficiency testing (PT) records and an interview with the Testing Personnel, it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the White Blood Cell Differential in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. See D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the laboratory's 2023 American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the Testing Personnel it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the White Blood Cell Differential in two (2) out of three (3) Hematology events. Findings include: 1. A review of the laboratory's 2023 API PT records revealed White Blood Cell Differential scores of less than eighty percent for the following hematology events: a. 2023-1: score of 0% b. 2023-2: score of 4% 2. A telephone interview conducted on 9/8/23 at approximately 12:00 PM with the Testing Personnel confirmed the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview with the laboratory director and testing personnel (TP#1 and TP#2), the laboratory failed to report SARS-CoV-2 test results as required for 25 of 25 days patients were tested from January through October 2022. Findings include: 1. The COVID 19 Antigen Test Result Logs were reviewed from January 3, 2022 through October 20, 2022. 2. Documentation revealed that SARS- CoV-2 test results were not reported as required for 9 days in January, 6 days in February, 1 day in March, 2 days in May, 2 days in June, 3 days in July, 1 day in September, and 1 day in October of 2022. 3. The laboratory was unaware of this reporting requirement and had never attempted to report any SARS-CoV-2 test results as required. 4. The laboratory reports performing 52 SARS-CoV-2 test during the period of review. 5. An interview conducted on 10/20/2022 at 1:00 PM with the laboratory director, TP #1 and TP #2, confirmed the laboratory did not attempt to report SARS-CoV-2 test results as required. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the surveyor's review of the written laboratory procedure manual and an interview with the testing personnel, the laboratory failed to have a written procedure for urine microscopy. Findings include: 1. A review of the laboratory's procedure manual revealed there was no written procedure for urine microscopy testing. 2. The laboratory reports performing approximately 490 urine microscopic exams annually. 3. An interview conducted on 10/20/2022 at 1:00 PM with the laboratory director, TP #1 and TP #2, confirmed the laboratory did not have a written procedure for urine microscopic exams. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview with the laboratory director and testing personnel (TP#1 and TP#2), the laboratory failed to report SARS-CoV-2 test results as required for 25 of 25 days patients were tested from January through October 2022. Findings include: 1. The COVID 19 Antigen Test Result Logs were reviewed from January 3, 2022 through October 20, 2022. 2. Documentation revealed that SARS- CoV-2 test results were not reported as required for 9 days in January, 6 days in February, 1 day in March, 2 days in May, 2 days in June, 3 days in July, 1 day in September, and 1 day in October of 2022. 3. The laboratory was unaware of this reporting requirement and had never attempted to report any SARS-CoV-2 test results as required. 4. The laboratory reports performing 52 SARS-CoV-2 test during the period of review. 5. An interview conducted on 10/20/2022 at 1:00 PM with the laboratory director, TP #1 and TP #2, confirmed the laboratory did not attempt to report SARS-CoV-2 test results as required. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the surveyor's review of the written laboratory procedure manual and an interview with the testing personnel, the laboratory failed to have a written procedure for urine microscopy. Findings include: 1. A review of the laboratory's procedure manual revealed there was no written procedure for urine microscopy testing. 2. The laboratory reports performing approximately 490 urine microscopic exams annually. 3. An interview conducted on 10/20/2022 at 1:00 PM with the laboratory director, TP #1 and TP #2, confirmed the laboratory did not have a written procedure for urine microscopic exams. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of education, training and competency records and staff interview, the lab director did not ensure the laboratory testing personnel had appropriate education and training for non-waived testing. Findings: 1. The testing person was hired in May of 2020. 2. The testing person had a foreign diploma and did not have an evaluation of her credentials determining equivalency to a United States education. 3.. The laboratory performed approximately 2,000 tests per month in 2020. 5. The Laboratory Director confirmed these findings during an interview on 7/29/20 at 12:30 pm. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory did not establish and maintain the accuracy of its urine tests at least twice annually. Findings: 1. A review of the API Proficiency testing for 2016, 2017, and 2018 showed the laboratory discontinued proficiency testing for urine creatinine, microalbumin, and urine sediments in 2018 and did not have other procedures to establish and maintain their accuracy. 2. The lab performed 120 urine creatinine and microalbumin tests on the DCA Vantage analyzer and 120 urine sediments in 2017. 3. The Laboratory Director confirmed these findings during an interview on 8/27/18 at 12:30 pm. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on review of education, training and competency records and staff interview, the lab director did not ensure the laboratory testing personnel had appropriate education and training for non-waived testing. Findings 1. The testing person was hired in August of 2017. 2. The testing person had a foreign diploma and did not have an evaluation of her credentials determining equivalency to a United States education. 3. There was no documented training for the testing person for any laboratory testing. 4. The laboratory performed 28,402 tests in 2017. 5. The Laboratory Director confirmed these findings during an interview on 8/27/18 at 12:30 pm. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of training and competency records and staff interview, the technical consultant failed to evaluate and document the performance of the testing person at least semiannually during the first year the individual tests patient specimens. Findings: 1. The testing person was hired in August of 2017 2. The technical consultant failed to document the testing person's competency semiannually during the first year of patient testing. 3. The Laboratory Director confirmed these findings during an interview on 8/27/18 at 12:30 pm. -- 2 of 2 --